Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine

Assess Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Admnd at 3 & 4 Mths & DTPa-HBV-IPV/Hib Vaccine Admnd at 5 Mths, Followed by DTPa-IPV/Hib Vaccine at 18 Mths in Infants Who Received hepatitisB Vaccine at Birth & at One Month of Age

To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will be enrolled in this study.

Inclusion criteria

• Subjects must have been enrolled in the Rota-028 study.
• Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
• Written informed consent obtained from the parent or guardian of the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• Subjects should have received two doses of hepatitis B vaccine: at birth and at approximately one month of age.

Exclusion criteria

• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.